Managing director of Iperion Life Sciences Consultancy, Frits Stulp.
Image: Atomwise CEO and co-founder Abraham Heifets
Managing director of Iperion Life Sciences Consultancy, Frits Stulp.
IDMP: Where are we now and what lies ahead?
With the pandemic and its disruption dominating all agendas in 2020, what has been the impact on European progress with IDMP and what can we expect in 2021, given the now magnified need for transformed medicines management? Frits Stulp at Iperion Life Sciences Consultancy recaps the main developments of the year gone by and looks ahead to what to expect next year.
It goes without saying that Covid-19 has dominated the headlines in life sciences in 2020. But it would be wrong to conclude that everything else has been shelved while focus and resources have been diverted to responding to the pandemic. In fact, Covid-19 has shone a light onto the broader potential for global data standards, including those defined via ISO IDMP (Identification of Medicinal Products) which Europe is now so close to implementing via the EMA SPOR programme.
Amid the disruption caused to just about everything over the last year, this has also been a time of great emphasis on healthcare and the role of the pharma organisations, marketing authorisation applicants and holders (MAAs and MAHs), and of regulators, in a crisis. Speed to market (bringing relevant medicinal products, for example new vaccines, to market swiftly), yet also thoroughness in safety and quality assessments, have become paramount and visible to a much greater degree in society.
Countries, governments, health care providers, entire societies are crying out for approved medicinal products, but no one can afford for standards and requirements to be compromised in the rush to deliver what’s needed. No one wants a vaccine with side-effects worse than the symptoms of Covid-19. So, stakeholders across industry and the regulatory community have had to perform a careful balancing act.
If only: how IDMP could have helped in the pandemic
If IDMP data-based regulatory submissions had been standard issue by now, the pharmacovigilance element of bringing new vaccines to market safely would be much easier to manage.
Although IDMP is about identifying medicines and their constituent substances and manufacturing specifics - and does not cover the clinical efficacy of a product - the ability to instantly determine where products were made, the batch they came from, the exact ingredients and more would play a crucial role in monitoring, managing any side effects, and in supporting regulatory preventions and interventions.
IDMP could have helped with the identification of new clinical trials, too, to track the composition and indications of newly developed products.
Currently we find ourselves in uncharted territory, in that soon we are likely to have multiple new vaccines being distributed across the globe, to be given to billions of people – the largest human population ever to be targeted at once. And, although the profiles of those vaccines look good, inevitably there will be side effects which regulators and the life sciences industry will need to react to responsibly.
IDMP could have helped with the identification of new clinical trials.
While IDMP doesn’t offer a definitive solution, the ISO IDMP data model does allow for medicinal products, their packaging, any different versions, ingredients, specific batches and who have manufactured them, to be differentiated as part of any vaccine-based track-and-trace effort. This information could also form the basis of any electronic vaccination-based passports that may become desired for use as part of travel restrictions and border controls.
Hindsight is a wonderful thing, and we are not there yet, but Covid has helped to crystallise the potential of data standards, such as IDMP, in real-world use cases, at a time when many life sciences companies continue to view the requirements as ‘just another compliance burden’, or ‘something to be left to one side until IDMP data-based marketing authorisation submissions are mandatory’ (expected to be the case across the EU by 2023).
There has been plenty going on in the background to progress IDMP in 2020, certainly in Europe. Over the last 12 months, the European Medicines Agency (EMA) completed its reorganisation and ‘futureproofing’ exercise. This milestone coincided with the arrival of the Agency’s new executive director, Emer Cooke, formerly of the World Health Organization (WHO), who took office in November.
Along with the National Competent Authority (NCAs) and industry co-chairs of ISO IDMP SPOR Task Force (which is focused on finalising the introduction of substance, product, organisation and referentials data) Task Force, Cooke’s EMA is committed to ensuring that any investments in the product data standards are reusable across a wide range of use cases – addressing critical everyday business processes.
This is significant. Up to now, EMA’s chief goals for IDMP have been to streamline the regulatory assessment and authorisation of medicinal products, and to support pharmacovigilance activities. Yet, if set up properly, standards-based master data about products could be used for all kinds of uses cases between industry and regulators – from clinical trial approvals and shortages management, to product serialisation and tracking.
Another crucial development towards this end in 2020 has been the replacement of the Common European Single Submission Portal (CESSP) initiative with an EMA-sponsored project. The Network is still looking for a technical solution to comply with ISO IDMP and exchange of Fast Healthcare Interoperability Resources messages between industry and the regulator. EU-wide agreement on data exchange between regulators and industry would be ideal, to ensure optimisation of processes and use cases.
Up to now, EMA’s chief goals for IDMP have been to streamline the regulatory assessment and authorisation of medicinal products.
All of these advances are building towards a stronger backbone and greater momentum behind IDMP, its rollout and its potential impact. This, combined with a growing awareness across all stakeholders of the value of high-quality reusable data in streamlining routine processes, is creating a new sense of purpose and urgency around the ISO standards – in Europe at least.
While trying to manage the impact of Covid, NCAs have had to deal with people shortages, staff working from home, and other process disruption. Meanwhile, the intense emphasis on healthcare has created new pressure for regulatory professionals and authorities to complete processes more efficiently and transparently than ever, harnessing modern thinking, tools and techniques. This mind-set is in line with the thinking behind ISO IDMP, which promotes data standards as the means through which to optimise and even automate information processing.
A further development which is helping to make a seemingly complex landscape easier to navigate and link to longer-term real-world benefits is a growing alignment between two important systems – the EU SRS (scientific database for substances) and EMA’s SPOR Substance Management Services (SMS) system, which distributes relevance substance information.
With all of these not insignificant achievements in 2020, we’re in a better position than ever to ensure that IDMP-based master data forms the basis of transformation of critical business processes, raising the standards above the purpose of compliance for its own sake.
The baton passes back to industry
So, what can we expect in 2021, and what should life sciences companies be doing now so that they keep pace with requirements - and put themselves in the best position to harness IDMP’s fullest potential?
Knowing that the model for submitting regulatory data within the regulatory processes - the so-called Target Operating Model (TOM) – will change, and that technology environments at EMA and NCAs will have to support this, the SPOR Task Force co-chairs have been working to set an optimum level of ambitions to allow positive forward movement. They have compromised on a two-step approach which works around any current limitations.
The first step has been to define electronic data submission for the centralised regulatory process only, via EMA’s Gateway and/or API. With fewer players involved initially, the initiative will be easier to control and will provide the means to test for any bugs or issues before extending SPOR-based data submissions to a more distributed regulatory scenario involving NCAs.
The first step has been to define electronic data submission for the centralised regulatory process.
In phase II, as the CESSP gives way to the new technical platform, MAHs will be able to submit data once to stakeholders at both EMA and NCAs. This step requires that the application forms are capable of supplying IDMP-ready messages using the provided technology.
This two-step process allows a ‘Europe of multiple speeds’ – the possibility that individual NCAs might each pick a different point at which to move to phase II. To contain that risk, the various stakeholders are working to secure a commitment to a capped transition period, so that the two systems don’t run in parallel indefinitely.
Perspective is everything: one company’s burden is another’s opportunity
In the meantime, the life sciences industry must accept and acknowledge that time is ticking on and that waiting for all of the stars to align perfectly before they take action is not an option.
European SPOR implementation guidance is approaching the completion of version two – following a huge effort by industry, technology vendors and consultants, which has been largely a labour of love. This guidance is expected to be published by Q1 2021. The clock will then start ticking towards SPOR data-based submissions: these will be possible within 12 months and become mandatory a year after that. That might sound a way off, but that compliant data-based submissions to be obligatory by Q1 2023 will be sobering for those companies that have relied on a hard compliance date remaining on a distant horizon.
Where companies persist in seeing SPOR and IDMP as a burden to be endured, the next years will be painful and increasingly demanding. Now is the time to put a stake in the ground and decide whether EMA’s mandate is the only driving force for change, or whether this is a defining moment to change the way they do things – to make life easier in the long run.
IDMP will have been seen up to now as just another secondary data set that has to be generated.
For many organisations, IDMP will have been seen up to now as just another secondary data set that has to be generated – much as IDMP’s predecessor, the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD), was treated by many companies. The alternative, which is much more desirable and prudent, is to treat the new, richer data sets as a backbone to their operations and an asset in support of primary business processes – the basis of all future regulatory information-based activity, and with application ultimately that extends beyond Europe.
In the US, structured product labelling started out as a secondary data set that companies created to keep the FDA happy - often outsourcing the formatting and submission to third parties. But the realisation is dawning that this treatment adds only cost, but no value to the business. In the meantime, other markets including Canada, Brazil, Singapore and potentially China are all embracing the notion of data standardisation and process transformation.
Making a fundamental change to regulatory information management approaches now, then, is likely to pay dividends in the long run – once multiple documents can be built from one definitive data set based on agreed international standards
Treat the pandemic as enlightenment to IDMP’s potential
The other way to bed in new thinking is to look for the pain points in routine, everyday activity – those times when regulatory, quality/PV/safety or clinical teams have to trawl through piles of documents to get to the information they need. Managing recalls is often a particularly painful reminder of the need for greater information visibility and product traceability. In 2020, managing supply shortages has been a considerable challenge, which more efficient and consistent information exchange would have helped alleviate.
And in 2021, the ability to trace where vaccines and Covid-linked treatments have ended up will be a critical need. As red tape has been relaxed to get products out, any gaps in administration will need to be backfilled, to allow PV teams, regulators and R&D teams to fulfil their obligations.
The ability to trace where vaccines and Covid-linked treatments have ended up will be a critical need.
The most important perspective of all though, as companies look ahead, is that of the patient. Today, as civilians, we have more insight into and control over our financial affairs than we do of our own health, and that must change.
The societal perspective on all of this must be to empower patients with all of the information they need about the medicines they take, how and where these products were made and what goes into them, so that we can start to understand for ourselves what might be triggering or aggravating our allergies, giving us headaches or sapping our energy.
This reality isn’t that far away. It just needs proper data that all parties can align and refer to in the definition of medicines. It really is that simple – and that’s what we should all keep in mind in 2021, whatever path the Covid crisis takes next and whatever immediate requirements the regulators have prioritised.